The Perfect-CR Implementation Study
The Effect of Audit and Feedback Within a National Registry and Implementation Support on Guideline Adherence and Patient Outcomes in Cardiac Rehabilitation: an Open-label Cluster-randomized Effectiveness-implementation Hybrid Trial
1 other identifier
interventional
75
1 country
1
Brief Summary
The goal of this open-label cluster-randomized effectiveness-implementation hybrid trial is to study whether a) audit and feedback of cardiac rehabilitation service delivery within a national quality registry and b) structured implementation support can improve center-level adherence to guidelines and short and long-term patient-level outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
November 29, 2024
November 1, 2024
3.2 years
March 23, 2023
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence score
The adherence score reflects center-level adherence to CR processes and structures as recommended in national guidelines on secondary prevention. The score is derived from 39 variables capturing guideline-directed CR structure and processes collected on center-level through the national cardiac registry SWEDEHEART. The score ranges from 0 (worst) to 39 (best).
3 years
Secondary Outcomes (15)
Blood pressure target attainment
One year
Systolic blood pressure
One year
Low-density lipoprotein cholesterol target attainment
One year
Low-density lipoprotein cholesterol
One year
Self-reported quality of life
One year
- +10 more secondary outcomes
Study Arms (3)
Usual care
NO INTERVENTIONImplementation of national guidelines on secondary prevention according to local plan and preferences
Audit and feedback
ACTIVE COMPARATORAudit and feedback on implementation of national guidelines on secondary prevention through the national quality registry SWEDEHEART
Implementation support
ACTIVE COMPARATORAudit and feedback through the national quality registry SWEDEHEART and structured implementation support for implementation of national guidelines on secondary prevention
Interventions
Centres answer CR process and structure variables through the SWEDEHEART registry every six months for three years. Feedback will be accessible online and through annual reports, enabling comparisons with own prior and other centres´ results.
On-site support to implement guidelines on secondary prevention applying practice facilitation - a multifaceted approach carried out by CR experts who enable personnel at intervention centres to address and overcome challenges in implementing guidelines.
Eligibility Criteria
You may qualify if:
- Centres report to the SWEDEHEART registry
You may not qualify if:
- Unwillingness to participate in the study
- Patient-level
- Diagnosis of a type 1 MI registered in the SWEDEHEART registry
- Age 18-79 years at discharge from hospital
- Attended at least two follow-up visits at CR centres included in the study
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skane University Hospitallead
- Lund Universitycollaborator
- Uppsala Universitycollaborator
Study Sites (1)
Skåne University Hospital
Malmo, 20502, Sweden
Related Publications (1)
Michelsen HO, Lidin M, Back M, Duncan TS, Ekman B, Hagstrom E, Hagglund M, Lindahl B, Schlyter M, Leosdottir M. The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial. Implement Sci. 2024 May 24;19(1):35. doi: 10.1186/s13012-024-01366-8.
PMID: 38790045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margret Leosdottir
Skane University Hospital Malmö
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Cardiology Consultant, Associate Professor
Study Record Dates
First Submitted
March 23, 2023
First Posted
June 5, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2030
Last Updated
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
The data to be used in this study is based on the SWEDEHEART registry. Access to data from the registry needs to be applied for and third-party data usage is not allowed, irrespective of whether the data contain potentially identifying or sensitive data or not. Instead, given ethical study approval from the Swedish Ethical Review Authority, access to SWEDEHEART data can be applied for from the Uppsala Clinical Research Center (UCR) in Sweden. Further information can be found on the UCR www.ucr.uu.se/en/ and Swedish Ethical Review Authority etikprovningsmyndigheten.se/ websites.